Journal of women's health
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Journal of women's health · Apr 2021
Randomized Controlled TrialThe Patient Experience of Premenopausal Women Treated with Bremelanotide for Hypoactive Sexual Desire Disorder: RECONNECT Exit Study Results.
Background: Hypoactive sexual desire disorder (HSDD) has a significant negative impact on women's overall health and relationships with their partners. Primary analyses from the RECONNECT clinical trials demonstrated statistically significant and clinically meaningful improvements in sexual desire and related distress with bremelanotide relative to placebo in premenopausal women with HSDD. Exit surveys and patient interviews were conducted to evaluate the impact of HSDD and bremelanotide treatment from the patient's perspective. Materials and Methods: Upon completion of the double-blind study but before participation in the open-label extension, up to 250 participants were recruited to complete the quantitative exit survey (17 questions). ⋯ Participants who received bremelanotide described increased feelings of sexual desire, physical arousal, and improvements in overall quality of their sexual activities in their partner relationship. In comparison, women taking placebo reported benefits that did not include the physiological responses described by women receiving bremelanotide, such as positive experiences of seeking HSDD treatment and improved communication with their partner. Conclusions: Exit surveys and patient interviews support the primary findings from RECONNECT and provide quantitative and qualitative assessments of the impact of HSDD on patients' quality of life and the patients' perspectives on the impact of bremelanotide. Clinical trial numbers NCT02333071, NCT02338960.
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Journal of women's health · Apr 2021
Practice Guideline Meta AnalysisInternational Society for the Study of Women's Sexual Health Clinical Practice Guideline for the Use of Systemic Testosterone for Hypoactive Sexual Desire Disorder in Women.
Background: The Global Consensus Position Statement on the Use of Testosterone Therapy for Women (Global Position Statement) recommended testosterone therapy for postmenopausal women with hypoactive sexual desire disorder (HSDD). Aim: To provide a clinical practice guideline for the use of testosterone including identification of patients, laboratory testing, dosing, post-treatment monitoring, and follow-up care in women with HSDD. Methods: The International Society for the Study of Women's Sexual Health appointed a multidisciplinary panel of experts who performed a literature review of original research, meta-analyses, review papers, and consensus guidelines regarding testosterone use in women. ⋯ Strengths & Limitations: This evidence-based guideline builds on a recently published comprehensive meta-analysis and the Global Position Statement endorsed by numerous societies. The limitation is that testosterone therapy is not approved for women by most regulatory agencies, thereby making prescribing and proper dosing challenging. Conclusion: Despite substantial evidence regarding safety, efficacy, and clinical use, access to testosterone therapy for the treatment of HSDD in women remains a significant unmet need.
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Journal of women's health · Apr 2021
The Factor Reliability and Convergent Validity of the Patient Health Questionnaire-4 Among an International Sample of Pregnant Women.
Background: Pregnant women are at an increased risk for anxiety and depression, but a majority of women go untreated due to a high rate of undetected symptoms. The 4-item Patient Health Questionnaire (PHQ-4) is an ultrabrief screening instrument for anxiety and depression with sound psychometric properties demonstrated in the general population and primary care, but not among pregnant women. The aim of this study was to provide initial evidence of the validity and reliability of the PHQ-4 among pregnant women. Materials and Methods: Data from an international sample of 1148 pregnant women who participated in an online cross-sectional survey were examined using a confirmatory factor analysis (CFA) and multigroup analysis approaches. ⋯ Coefficient H values of 0.74 for anxiety and 0.70 for depression suggested good factor reliability. Conclusions: This is the first study demonstrating initial evidence supporting the validity and reliability of the PHQ-4 in pregnant women. Should this study be replicated, a clinical interview, which is the gold standard procedure, should be included. Regardless, the PHQ-4 may be a useful ultrabrief resource for maternal mental health clinicians and health care providers who need to identify potential cases of anxiety and depression in pregnant women using efficient and evidence-based tools.
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Journal of women's health · Apr 2021
Randomized Controlled TrialTrauma-Informed Personalized Scripts to Address Partner Violence and Reproductive Coercion: Follow-Up Findings from an Implementation Randomized Controlled Trial Study.
Background: Intimate partner violence (IPV) and reproductive coercion impact women seeking care at family planning (FP) clinics. Interventions to facilitate patient-provider conversations about healthy relationships are needed. We sought to determine the added effect of providing psychoeducational messages to patients compared with tailored provider scripts alone on sexual and reproductive health outcomes at 4-6 months. ⋯ Conclusions: We show no added benefit of patient-activation messages compared with provider scripts alone. Findings suggest potential utility of provider scripts in addressing reproductive coercion and contraceptive uptake (Trial Registration No. NCT02782728).